Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)— 510(k) K243535
Substantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.
FDA 510(k) clearance K243535 for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U), Substantially Equivalent on 2025-03-07. Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Product code
- Code FBN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Shanghai, CN
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More clearances from Shanghai SeeGen Photoelectric Technology Co., Ltd.
view allAdverse events under product code FBN
product code FBN- Death
- 8
- Malfunction
- 951
- Total
- 959
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.